Antegrade Cerebral Perfusion and Retrograde Inferior Vena Caval Perfusion for Total Aortic Arch Replacement (CARTAR)

April 8, 2019 updated by: Lei Du, West China Hospital

The Effect of Combination of Selective Antegrade Cerebral Perfusion With Retrograde Inferior Vena Caval Perfusion on the Outcomes in Patients Underwent Total Aortic Arch Replacement

This study is designed as a multicenter, randomized, assessor- blinded clinical trial.The primary aim of this trial is to assess whether retrograde inferior venal caval perfusion combined selective antegrade cerebral perfusion(ACP)under mild hypothermia, compared with moderate hypothermia combined with selective ACP alone, improves the outcome for the patients undergoing total aortic arch replacement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Weimin Li, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient aged 18 yr-65yr
  2. Patient underwent total aortic arch replacement

Exclusion Criteria:

  1. Inability to understand/give informed consent,
  2. Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial.
  3. Inability to obtain superior and inferior vena caval cannulation due to pericardium adhesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: RIVP group
After total cardiopulmonary bypass was initiated, the patient is cooled slowly to induce moderate hypothermia(28-30℃). The combination of selective antegrade cerebral perfusion and retrograde inferior vena caval perfusion is performed. The antegrade perfusion flow rate was is maintained at 6-12 mL/min/kg.Pump pressure of retrograde perfusion was is maintained at 20-30 mmHg, and blood flow was is maintained at 8-12 mL/min/kg.
Procedure: Retrograde Inferior Vena Caval Perfusion
Retrograde Inferior Vena Caval Perfusion is achieved by tethering the inferior vena cava with a band around the cannula and by clamping the distal end of the inferior vena cava drainage tube, which allowed a pump to drive oxygenated blood into the inferior vena cava. Pump pressure is maintained at 20-30 mmHg, and blood flow is maintained at 8-12 mL/min/kg. The aim of RIVP is to maintain the lower body perfusion during circulation arrest, and reduce the ischemia-associated vital organ injury.
Other Names:
  • Select antegrade cerebral perfusion
Active Comparator: ACP group
After total cardiopulmonary bypass was initiated, the patient is cooled slowly to induce moderate hypothermia(26-28℃). Only select antegrade cerebral perfusion is performed by maintaining the flow rate at 6-12 mL/min/kg.
Procedure: Select antegrade cerebral perfusion
Antegrade cerebral perfusion is achieved using a 12 F cannula inserted into the brachiocephalic artery or right axillary artery. The antegrade perfusion flow rate is maintained at 6-12 mL/min/kg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite major complications
Time Frame: up to 12 months
Newly Postoperative Renal Failure;Surgical Re-exploration；Operative Mortality;Deep Sternal Wound Infection;Stroke/Cerebrovascular Accident;Paraplegia
up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Respiratory Failure
Time Frame: up to 30 days
up to 30 days
Transient Neurological Deficit
Time Frame: up to 30 days
The occurrence of postoperative agitation, confusion, delirium, obtundation or a transient focal neurologic deficit (resolution within 72 hours) without any evidence of new structural abnormality on computed tomography or magnetic resonance imaging.
up to 30 days
Acute Kidney Injury not requiring Dialysis
Time Frame: up to 30 days
Kidney Disease Improving Global Outcomes (KDIGO) guidelines17
up to 30 days
Myocardial Infarction
Time Frame: up to 30 days
up to 30 days
Postoperative Prolonged Intubation
Time Frame: up to 30 days
patients aged 18 years and older who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours patients aged 18 years and older undergoing isolated CABG who require intubation for more than 24 hours Patients who require intubation for more than 24 hours
up to 30 days
Paraparesis
Time Frame: up to 30 days
Motor weakness in any lower extremity muscle group or unilateral paraplegia (Tarlov score 1-4 or, if present, a score of zero in a single lower extremity)
up to 30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of volume of blood products transfusion
Time Frame: up to 30 days
The number of units of packed red blood cells , fresh-frozen plasma, pooled platelets and cryoprecipitate administered was collected from blood bank records
up to 30 days
Length of ICU stay
Time Frame: up to 30 days
The duration of staying ICU postoperatively, time between administrated in ICU after the procedure to discharge from the ICU
up to 30 days
Length of postoperative stay
Time Frame: up to 30 days
the number of days between procedure and discharge, including any time patients spent at hospitals or long-term acute care facilities after transfer from our institution
up to 30 days
Gastrointestinal bleed
Time Frame: up to 30 days
Gastrointestinal bleed is defined as unambiguous clinical or endoscopic evidence of blood in the gastrointestinal tract. Upper gastrointestinal bleeding (or haemorrhage) is that originating proximal to the ligament of Treitz, in practice from the oesophagus, stomach and duodenum. Lower gastrointestinal bleeding is that originating from the small bowel or colon.
up to 30 days
Postoperative ascites
Time Frame: up to 30 days
Accumulation or retention of free fluid in the abdominal peritoneal cavity between the tissues lining the abdomen and abdominal organs. The fluid may be serous, hemorrhagic, or the result of inflammation or tumor metastasis to the peritoneum.
up to 30 days
Death
Time Frame: 12 months
since incident surgery
12 months
New onset dialysis (since incident surgery) status
Time Frame: 12 months
Renal failure requiring dialysis
12 months
Stroke
Time Frame: 12 months
Any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain
12 months
Myocardial infarction
Time Frame: 12 months
Increase in serum cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and at least one of the following criteria: symptoms of ischaemia; new or presumed new significant ST segment or T wave ECG changes or new left bundle branch block; development of pathological Q waves on ECG; radiological or echocardiographic evidence of new loss of viable myocardium or new regional wall motion abnormality; identification of an intracoronary thrombus at angiography or autopsy（since incident surgery）
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lei Du, M.D, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WCH-2018-24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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